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NCT06323135 Clinical Trial

Nutrition Assessment in Advanced Cancer Patients

Advanced Cancer Clinical Trial

Official title:
The Predictive Value of PG-SGA Criteria in Advanced Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06323135
Other study ID # 2019-725
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 17, 2019
Est. completion date September 11, 2023

Study information
Verified date March 2024
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this retrospective observational study is to evaluate the prognostic value of nutrition assessment tool in advanced cancers. We aim to evaluate the clinical utility of nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would help the clinicians to make tailored decision for this population.

Description:

To date, cancer is the leading cause of disability and death globally. Cancer-related mortality rate differs significantly across the world, reflecting varying patterns of inherent genetic heterogeneity and medical resources available factors. Considerable proportions of patients remained diagnosed with advanced-stage cancers at the initial visit, given the differences between demographic geographical and socioeconomic regions, and inadequate resources of China. For this reason, how to make adequate clinical management and prognostic prediction for advanced-stage cancers are still challenged. Malnutrition is prevalent in cancer patients, accounting for approximately 20% to 80% of the cancer population, which plays a key role in the short-and long-term clinical outcomes. Providing more real-world clinical evidence for supporting the beneficial role of nutritional screening in advanced-stage cancers can help to improve clinical nursing care for advanced-stage patients, especially in developing countries. The malnutrition status of cancer patients is often accompanied by symptoms of poor nutrient intake, weight loss, progress of systemic inflammatory disorders, and upregulated immune responses. Emerging evidence has determined that the systemic pro-inflammation status was positively associated with elevated malnutritional scores and consistently predicted the worse survival probabilities of cancer patients. Notably, the European Society for Clinical Nutrition and Metabolism (ESPEN) expert consensus regarding the action against cancer-related malnutrition recommended that nutritionists were encouraged to use additional biomarkers to assess the severity of cancer-related systemic inflammation burdens, which might enhance the predictive value of existing malnutritional screening tools in clinical practice. Although the PG-SGA criteria, the nutrition assessment tool, has been widely interpreted and validated to be a simple and easily available tool for the prognosis prediction for varied cancers in recent years, the criteria of the PG-SGA lacked the calculation of systemic inflammatory burdens. Whether the inflammatory indicators could be the surrogate biomarkers for enhancing the prediction ability of PG-SGA for advanced-stage cancer patients remains less studied. Therefore, we aim to fill the mentioned research gaps to conduct this observational study.

Recruitment information / eligibility
Status Completed
Enrollment 2115
Est. completion date September 11, 2023
Est. primary completion date September 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Advanced cancers Exclusion Criteria: - Aged below 18 - Incomplete blood tests - Incomplete follow-up data

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China West China Hospital, Sichuan Universit Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality the all-cause mortality of cancer patients Nov 11, 2019 to 11 Sep, 2023
Secondary length of stay in hospital the days of length of stay in hospital Nov 11, 2019 to 11 Sep, 2023
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